FDA WARNING_LETTER - Zylstra Dairy Farms, Inc. - January 07, 2015

On January 7, 2015, the FDA investigated Zylstra Dairy Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a dairy cow for slaughter on April 4, 2014, which USDA testing revealed had a flunixin residue of 0.304 ppm in its liver, exceeding the FDA tolerance of 0.125 ppm (21 CFR 556.286(b)(1)(i)). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), as it contained an unsafe new animal drug.

Furthermore, the investigation found that animals were held under insanitary conditions, specifically a failure to identify and segregate medicated animals, increasing the likelihood of harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

Zylstra Dairy Farm must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is required within fifteen working days of receiving the letter, to be